510(k) · Cleared
ClearedThe C100 Contactless Breathing Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circadia Technologies, Ltd. · BZQ Monitor, Breathing Frequency
Cleared on Jun 24, 2020 as substantially equivalent to K103631 (Biancamed Limited, 2011) after a 121-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Jun 24, 2020
- Review
- 121 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K913396 (1992). 52 ancestors in all, the oldest K830295 (1983). No later device cites it as a predicate yet.
- Root · 8 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 7 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 6 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 5 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 4 generations backK041904 Compass F10 SystemMedcare Flaga · 2004
- 3 generations backK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- 2 generations backK090273 Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai…Kai Sensors, Inc. · 2009
- 1 generation backK103631 Sleepminder Breathing Frequency IndicatorBiancamed Limited · 2011
- This deviceK200445 The C100 Contactless Breathing MonitorCircadia Technologies, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −7 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −6 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −5 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −4 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| −3 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| −2 | K090273 | Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot… | Kai Sensors, Inc. | 2009 | — |
| −1 | K103631 | Sleepminder Breathing Frequency Indicator | Biancamed Limited | 2011 | — |
| 0 (this device) | K200445 | The C100 Contactless Breathing Monitor | Circadia Technologies, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZQ device
- #1 K251326 Respiration Rate algorithmscore 20.2 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103631 | Sleepminder Breathing Frequency IndicatorSummary page 5…Predicate Device Identification The Circadia C100 System is substantially equivalent to the SleepMinder Breathing Frequency Indicator (model BM07) from BiancaMed Ltd (K103631). The Circadia C100 System has the same intended use and similar indications, technological characteristics, and principles of o… | 2011 |
| † | K122516 | Embletta MPR | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 9 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 52 ancestors have a recall of any class.
How does its category compare?
All BZQ devicesBZQ Monitor, Breathing Frequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · BZQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZQ
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZQ
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZQ
2in 2022
MAUDE reports naming product code BZQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 7 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 121 | 0 | 1 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 3 | 261 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 3 | 198 | 0 | 10 |
| 2019 | 1 | — | 0 | 13 |
| 2020 | 2 | — | 0 | 10 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 3 | 198 | 0 | 2 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 7 | 255 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Circadia C 100 System is indicated for both contactless spot checking and continuous measurement of respiratory rate data as part of a vital signs assessment. The system records, transmits, and displays respiratory rate from multiple connected devices for retrospective analysis only. The system is intended to be used under the care of clinicians and medically qualified personnel. The system is indicated for use in adult patients during no-motion…
Read the full statement (132 words)
The Circadia C 100 System is indicated for both contactless spot checking and continuous measurement of respiratory rate data as part of a vital signs assessment. The system records, transmits, and displays respiratory rate from multiple connected devices for retrospective analysis only. The system is intended to be used under the care of clinicians and medically qualified personnel.
The system is indicated for use in adult patients during no-motion conditions, for patients in health care facilities. It is available for sale only upon the order of a physician or licensed health care provider.
The Circadia C 100 System is not indicated for active patient monitoring, as it does not provide alarms for timely response in life-threatening situations. It is not intended to monitor vital signs. This system is not an apnea monitor
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200445 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200445: The C100 Contactless Breathing Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200445
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026